|
Delaware
|
|
51-0596811
|
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(IRS Employer
Identification No.)
|
100 Acorn Park Drive
|
|
|
Cambridge, Massachusetts
|
|
02140
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Title of each class
|
|
Trading symbol(s)
|
|
Name of each exchange on which registered
|
Common stock, $0.001 par value per share
|
|
GNCA
|
|
NASDAQ Capital Market
|
Large accelerated filer
|
¨
|
|
|
|
|
Accelerated filer
|
x
|
Non-accelerated filer
|
¨
|
|
|
|
|
Smaller reporting company
|
x
|
|
|
|
|
|
|
Emerging growth company
|
¨
|
|
•
|
our estimates regarding the timing and amount of funds we require to conduct clinical trials for GEN-009, to continue preclinical studies and file an investigational new drug (“IND”) for GEN-011, to continue preclinical studies for our other product candidates and to continue our investments in immuno-oncology;
|
•
|
our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing;
|
•
|
the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;
|
•
|
the availability of materials and equipment, and the potential disruptions in supply chains resulting from the international public health emergency associated with the novel coronavirus (COVID-19);
|
•
|
the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
|
•
|
our intellectual property position;
|
•
|
the rate and degree of market acceptance and clinical utility of any approved product candidate;
|
•
|
our ability to quickly and efficiently identify and develop product candidates; and
|
•
|
our commercialization, marketing and manufacturing capabilities and strategies.
|
|
|
Page
|
||
|
||||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
|
|||
|
||||
|
||||
|
||||
|
|
|
|
|
|
||||
|
||||
|
|
March 31,
2020 |
|
December 31,
2019
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
26,509
|
|
|
$
|
40,127
|
|
Prepaid expenses and other current assets
|
2,562
|
|
|
1,457
|
|
||
Total current assets
|
29,071
|
|
|
41,584
|
|
||
Property and equipment, net
|
2,474
|
|
|
2,617
|
|
||
Right of use assets
|
11,782
|
|
|
6,306
|
|
||
Restricted cash
|
631
|
|
|
631
|
|
||
Other non-current assets
|
1,234
|
|
|
1,473
|
|
||
Total assets
|
$
|
45,192
|
|
|
$
|
52,611
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
860
|
|
|
$
|
553
|
|
Accrued expenses and other current liabilities
|
4,077
|
|
|
4,611
|
|
||
Lease liabilities
|
2,028
|
|
|
1,117
|
|
||
Current portion of long-term debt
|
7,700
|
|
|
—
|
|
||
Total current liabilities
|
14,665
|
|
|
6,281
|
|
||
Non-current liabilities:
|
|
|
|
|
|
||
Long-term debt, net of current portion
|
5,815
|
|
|
13,407
|
|
||
Warrant liability
|
1,705
|
|
|
2,486
|
|
||
Lease liabilities, net of current portion
|
9,994
|
|
|
5,395
|
|
||
Total liabilities
|
32,179
|
|
|
27,569
|
|
||
Commitments and contingencies (Note 5)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock, $0.001 par value; (shares authorized of 25,000,000 at March 31, 2020 and December 31, 2019; 1,635 shares issued and outstanding at March 31, 2020 and December 31, 2019)
|
701
|
|
|
701
|
|
||
Common stock, $0.001 par value; (shares authorized of 85,000,000 at March 31, 2020 and December 31, 2019, 27,643,773 shares issued and outstanding at March 31, 2020 and 27,452,900 shares issued and outstanding at December 31, 2019)
|
28
|
|
|
27
|
|
||
Additional paid-in capital
|
356,091
|
|
|
355,268
|
|
||
Accumulated deficit
|
(343,807
|
)
|
|
(330,954
|
)
|
||
Total stockholders’ equity
|
13,013
|
|
|
25,042
|
|
||
Total liabilities and stockholders’ equity
|
$
|
45,192
|
|
|
$
|
52,611
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Operating expenses:
|
|
|
|
||||
Research and development
|
$
|
9,987
|
|
|
$
|
6,460
|
|
General and administrative
|
3,388
|
|
|
3,017
|
|
||
Total operating expenses
|
13,375
|
|
|
9,477
|
|
||
Loss from operations
|
(13,375
|
)
|
|
(9,477
|
)
|
||
Other income (expense):
|
|
|
|
|
|
||
Change in fair value of warrants
|
781
|
|
|
(5,787
|
)
|
||
Interest expense, net
|
(259
|
)
|
|
(302
|
)
|
||
Other income (expense)
|
—
|
|
|
(1
|
)
|
||
Total other income (expense)
|
522
|
|
|
(6,090
|
)
|
||
Net loss
|
$
|
(12,853
|
)
|
|
$
|
(15,567
|
)
|
|
|
|
|
||||
Comprehensive loss
|
$
|
(12,853
|
)
|
|
$
|
(15,567
|
)
|
Net loss per share - basic and diluted
|
$
|
(0.46
|
)
|
|
$
|
(1.22
|
)
|
Weighted-average number of common shares used in computing net loss per share
|
28,141
|
|
|
12,713
|
|
|
|
|
|
|
|
Preferred Shares Amount
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity
|
|||||||||||
|
|
Common Shares
|
|
|
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2019
|
|
27,453
|
|
|
$
|
27
|
|
|
$
|
701
|
|
|
$
|
355,268
|
|
|
$
|
(330,954
|
)
|
|
$
|
25,042
|
|
Issuance of common stock, net
|
|
187
|
|
|
1
|
|
|
—
|
|
|
439
|
|
|
—
|
|
|
440
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
384
|
|
|
—
|
|
|
384
|
|
|||||
Issuance of common stock under employee benefit plans
|
|
4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(12,853
|
)
|
|
(12,853
|
)
|
|||||
Balance at March 31, 2020
|
|
27,644
|
|
|
$
|
28
|
|
|
$
|
701
|
|
|
$
|
356,091
|
|
|
$
|
(343,807
|
)
|
|
$
|
13,013
|
|
|
|
|
|
|
|
Preferred Shares Amount
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity
|
|||||||||||
|
|
Common Shares
|
|
|
|
|
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2018
|
|
10,847
|
|
|
$
|
11
|
|
|
$
|
701
|
|
|
$
|
298,627
|
|
|
$
|
(292,004
|
)
|
|
$
|
7,335
|
|
Issuance of common stock, net
|
|
3,200
|
|
|
3
|
|
|
—
|
|
|
14,023
|
|
|
—
|
|
|
14,026
|
|
|||||
Exercise of stock options
|
|
3
|
|
|
—
|
|
|
—
|
|
|
12
|
|
|
—
|
|
|
12
|
|
|||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
429
|
|
|
—
|
|
|
429
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,567
|
)
|
|
(15,567
|
)
|
|||||
Balance at March 31, 2019
|
|
14,050
|
|
|
$
|
14
|
|
|
$
|
701
|
|
|
$
|
313,091
|
|
|
$
|
(307,571
|
)
|
|
$
|
6,235
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Operating activities
|
|
|
|
|
|
||
Net loss
|
$
|
(12,853
|
)
|
|
$
|
(15,567
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|||
Depreciation and amortization
|
276
|
|
|
272
|
|
||
Stock-based compensation
|
384
|
|
|
429
|
|
||
Change in fair value of warrant liability
|
(781
|
)
|
|
5,787
|
|
||
Gain on sale of equipment
|
(13
|
)
|
|
—
|
|
||
Non-cash interest expense
|
109
|
|
|
162
|
|
||
Asset impairment
|
97
|
|
|
—
|
|
||
Changes in operating assets and liabilities
|
(1,015
|
)
|
|
(1,382
|
)
|
||
Net cash used in operating activities
|
(13,796
|
)
|
|
(10,299
|
)
|
||
Investing activities
|
|
|
|
|
|||
Purchases of property and equipment
|
(233
|
)
|
|
(221
|
)
|
||
Proceeds from sale of equipment
|
16
|
|
|
—
|
|
||
Net cash used in investing activities
|
(217
|
)
|
|
(221
|
)
|
||
Financing activities
|
|
|
|
|
|
||
Proceeds from issuance of common stock, net
|
440
|
|
|
—
|
|
||
Payments on finance lease
|
(45
|
)
|
|
—
|
|
||
Proceeds from equity offerings, net of issuance costs
|
—
|
|
|
14,026
|
|
||
Repayment of long-term debt
|
—
|
|
|
(841
|
)
|
||
Proceeds from exercise of stock options
|
—
|
|
|
12
|
|
||
Net cash provided by financing activities
|
395
|
|
|
13,197
|
|
||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
$
|
(13,618
|
)
|
|
$
|
2,677
|
|
Cash, cash equivalents and restricted cash at beginning of period
|
40,758
|
|
|
26,677
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
27,140
|
|
|
$
|
29,354
|
|
Non-cash financing activities and supplemental cash flow information
|
|
|
|
|
|
||
Right-of-use asset obtained in exchange for lease liabilities
|
$
|
5,931
|
|
|
$
|
1,686
|
|
Cash paid in connection with operating lease liabilities
|
$
|
394
|
|
|
$
|
406
|
|
Cash paid for interest
|
$
|
261
|
|
|
$
|
289
|
|
•
|
Level 1—Fair values are determined by utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access;
|
•
|
Level 2—Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and
|
•
|
Level 3—Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
|
|
|
|
Quoted prices in active markets
|
|
Significant other observable inputs
|
|
Significant unobservable inputs
|
||||||||
|
Total
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||||
March 31, 2020
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
25,985
|
|
|
$
|
25,985
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
25,985
|
|
|
$
|
25,985
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
1,705
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,705
|
|
Total liabilities
|
$
|
1,705
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,705
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2019
|
|
|
|
|
|
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
39,971
|
|
|
$
|
39,971
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
39,971
|
|
|
$
|
39,971
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
2,486
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,486
|
|
Total liabilities
|
$
|
2,486
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,486
|
|
|
|
Warrant Liability
|
||
Balance at December 31, 2019
|
|
$
|
2,486
|
|
Change in fair value
|
|
(781
|
)
|
|
Balance at March 31, 2020
|
|
$
|
1,705
|
|
|
March 31,
|
|
December 31,
|
||||
|
2020
|
|
2019
|
||||
Research and development costs
|
$
|
2,507
|
|
|
$
|
1,607
|
|
Payroll and employee-related costs
|
730
|
|
|
2,245
|
|
||
Other current liabilities
|
840
|
|
|
759
|
|
||
Total
|
$
|
4,077
|
|
|
$
|
4,611
|
|
|
|
March 31, 2020
|
|
March 31, 2019
|
||
Weighted average remaining lease term in years
|
|
4.92
|
|
|
0.92
|
|
Weighted average discount rate
|
|
8.13
|
%
|
|
10.00
|
%
|
Leases (in thousands)
|
|
Classification
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Assets
|
|
|
|
|
|
|
||||
Operating
|
|
Lease ROU asset
|
|
$
|
11,663
|
|
|
$
|
6,156
|
|
Finance
|
|
Lease ROU asset
|
|
119
|
|
|
150
|
|
||
Total lease assets
|
|
|
|
$
|
11,782
|
|
|
$
|
6,306
|
|
Liabilities
|
|
|
|
|
|
|
||||
Current
|
|
|
|
|
|
|
||||
Operating
|
|
Lease liabilities
|
|
$
|
1,921
|
|
|
$
|
990
|
|
Finance
|
|
Lease liabilities
|
|
107
|
|
|
127
|
|
||
Non-current
|
|
|
|
|
|
|
||||
Operating
|
|
Lease liabilities, net of current portion
|
|
9,994
|
|
|
5,373
|
|
||
Finance
|
|
Lease liabilities, net of current portion
|
|
—
|
|
|
22
|
|
||
Total lease liabilities
|
|
|
|
$
|
12,022
|
|
|
$
|
6,512
|
|
|
Operating leases
|
|
Finance lease
|
|
Total
|
||||||
2020
|
$
|
2,110
|
|
|
$
|
89
|
|
|
$
|
2,199
|
|
2021
|
2,871
|
|
|
23
|
|
|
2,894
|
|
|||
2022
|
2,943
|
|
|
—
|
|
|
2,943
|
|
|||
2023
|
3,017
|
|
|
—
|
|
|
3,017
|
|
|||
2024 and thereafter
|
3,609
|
|
|
—
|
|
|
3,609
|
|
|||
Total lease payments
|
$
|
14,550
|
|
|
$
|
112
|
|
|
$
|
14,662
|
|
Less imputed interest
|
(2,635
|
)
|
|
(5
|
)
|
|
(2,640
|
)
|
|||
Total
|
$
|
11,915
|
|
|
$
|
107
|
|
|
$
|
12,022
|
|
|
March 31, 2020
|
||
2020
|
$
|
—
|
|
2021
|
13,960
|
|
|
Total
|
$
|
13,960
|
|
|
|
Shares
|
|
Exercise price
|
|
Expiration date
|
|
Classification
|
|||
Hercules Warrant
|
|
41,177
|
|
|
$
|
6.80
|
|
|
Q2 2023
|
|
Equity
|
2018 Public Offering Warrants
|
|
3,616,944
|
|
|
$
|
9.60
|
|
|
Q1 2023
|
|
Liability
|
Private Placement Warrants
|
|
932,812
|
|
|
$
|
4.52
|
|
|
Q1 2024
|
|
Equity
|
Pre-Funded Warrants
|
|
531,250
|
|
|
$
|
0.08
|
|
|
Q1 2039
|
|
Equity
|
|
|
5,122,183
|
|
|
|
|
|
|
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Stock price
|
|
$
|
1.72
|
|
|
$
|
2.07
|
|
Volatility
|
|
50.0% - 124.5%
|
|
|
50.0% - 116.6%
|
|
||
Remaining term (years)
|
|
2.8
|
|
|
3.1
|
|
||
Expected dividend yield
|
|
—
|
|
|
—
|
|
||
Risk-free rate
|
|
0.3
|
%
|
|
1.6
|
%
|
||
Annual acquisition event probability
|
|
30.0
|
%
|
|
20.0
|
%
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Research and development
|
160
|
|
|
182
|
|
||
General and administrative
|
$
|
224
|
|
|
$
|
247
|
|
Total
|
$
|
384
|
|
|
$
|
429
|
|
|
Shares
|
|
Weighted-Average
Exercise Price |
|
Weighted-Average
Remaining Contractual Term (years) |
|
Aggregate
Intrinsic Value |
|||||
Outstanding at December 31, 2019
|
1,323
|
|
|
$
|
11.65
|
|
|
|
|
$
|
—
|
|
Granted
|
66
|
|
|
$
|
1.99
|
|
|
|
|
|
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
Cancelled
|
(19
|
)
|
|
$
|
4.85
|
|
|
|
|
|
|
|
Outstanding at March 31, 2020
|
1,370
|
|
|
$
|
11.28
|
|
|
7.90
|
|
$
|
—
|
|
Exercisable at March 31, 2020
|
585
|
|
|
$
|
18.90
|
|
|
6.72
|
|
$
|
—
|
|
|
|
Shares
|
|
Weighted-Average Grant Date Fair Value
|
|||
Outstanding as of December 31, 2019
|
|
—
|
|
|
$
|
—
|
|
Granted
|
|
45
|
|
|
$
|
1.98
|
|
Vested
|
|
—
|
|
|
$
|
—
|
|
Forfeited/cancelled
|
|
—
|
|
|
$
|
—
|
|
Outstanding as of March 31, 2020
|
|
45
|
|
|
$
|
1.98
|
|
|
|
Three months ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Basic net loss per share:
|
|
|
|
|
||||
Numerator:
|
|
|
|
|
||||
Net loss (in thousands)
|
|
$
|
(12,853
|
)
|
|
$
|
(15,567
|
)
|
Denominator:
|
|
|
|
|
||||
Weighted average common stock outstanding - basic (in thousands)
|
|
28,141
|
|
|
12,713
|
|
||
Dilutive effect of shares of common stock equivalents resulting from common stock options and restricted stock units
|
|
—
|
|
|
—
|
|
||
Weighted average common stock outstanding - diluted
|
|
28,141
|
|
|
12,713
|
|
||
Net loss per share - basic and diluted
|
|
$
|
(0.46
|
)
|
|
$
|
(1.22
|
)
|
•
|
Part A of the trial is assessing the safety and immunogenicity of GEN-009 as monotherapy in certain cancer patients with no evidence of disease; and
|
•
|
Part B of the trial, for which we have commenced dosing patients, is designed to assess the safety, immunogenicity, and preliminary antitumor activity of GEN-009 in combination with ICI therapy in patients with advanced or metastatic tumors.
|
•
|
100% of patients had measurable CD4+ and CD8+ T cell responses to their GEN-009 vaccine;
|
•
|
Responses were detected against 99% of the administered vaccine neoantigens (N=88 administered antigens), a response rate in excess of that which has been reported previously in response to candidate neoantigen vaccines;
|
•
|
GEN-009 elicited CD8+ T cell responses ex vivo, which is a measure of T cell effector function, for 41% of vaccine neoantigens and CD4+ T cell responses to 51% of neoantigens;
|
•
|
GEN-009 elicited broad immune responses using an in vitro stimulation assay, which is a measure of central memory responses, with 87% of neoantigens eliciting a CD4+ response and 57% of neoantigens eliciting a CD8+ response;
|
•
|
GEN-009 was well tolerated, with no dose-limiting toxicities observed; and
|
•
|
Through April 8, 2020, only one of the eight vaccinated patients has developed a recurrent tumor.
|
•
|
salary and related expenses;
|
•
|
expenses incurred under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), consultants, and other vendors that conduct our clinical trials and preclinical activities;
|
•
|
costs of acquiring, developing, and manufacturing clinical trial materials and lab supplies; and
|
•
|
facility costs, depreciation, and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies.
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Phase 1/2a programs
|
$
|
4,793
|
|
|
$
|
4,720
|
|
Discovery and pre-IND
|
3,809
|
|
|
788
|
|
||
Other research and development
|
1,385
|
|
|
952
|
|
||
Total research and development
|
$
|
9,987
|
|
|
$
|
6,460
|
|
|
Three Months Ended March 31,
|
|
Increase
|
||||||||
(in thousands)
|
2020
|
|
2019
|
|
(Decrease)
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|||
Research and development
|
$
|
9,987
|
|
|
$
|
6,460
|
|
|
$
|
3,527
|
|
General and administrative
|
3,388
|
|
|
3,017
|
|
|
371
|
|
|||
Total operating expenses
|
13,375
|
|
|
9,477
|
|
|
3,898
|
|
|||
Loss from operations
|
(13,375
|
)
|
|
(9,477
|
)
|
|
3,898
|
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Change in fair value of warrants
|
781
|
|
|
(5,787
|
)
|
|
6,568
|
|
|||
Interest expense, net
|
(259
|
)
|
|
(302
|
)
|
|
43
|
|
|||
Other income (expense)
|
—
|
|
|
(1
|
)
|
|
1
|
|
|||
Total other income
|
522
|
|
|
(6,090
|
)
|
|
6,612
|
|
|||
Net loss
|
$
|
(12,853
|
)
|
|
$
|
(15,567
|
)
|
|
$
|
(2,714
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Net cash used in operating activities
|
$
|
(13,796
|
)
|
|
$
|
(10,299
|
)
|
Net cash used in investing activities
|
(217
|
)
|
|
(221
|
)
|
||
Net cash provided by financing activities
|
395
|
|
|
13,197
|
|
||
Net (decrease) increase in cash and cash equivalents
|
$
|
(13,618
|
)
|
|
$
|
2,677
|
|
•
|
the timing and costs of our planned clinical trials for GEN-009;
|
•
|
the progress, timing, and costs of manufacturing GEN-009 for planned clinical trials;
|
•
|
the outcome, timing, and costs of seeking regulatory approvals, including an IND application for GEN-011;
|
•
|
the initiation, progress, timing, costs, and results of preclinical studies and clinical trials for our other product candidates and potential product candidates;
|
•
|
the terms and timing of any future collaborations, grants, licensing, consulting, or other arrangements that we may establish;
|
•
|
the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone payments, royalty payments and patent prosecution fees that we are obligated to pay pursuant to our license agreements;
|
•
|
the costs of preparing, filing, and prosecuting patent applications, maintaining and protecting our intellectual property rights, and defending against intellectual property related claims;
|
•
|
the extent to which we in-license or acquire other products and technologies;
|
•
|
the receipt of marketing approval;
|
•
|
the costs of commercialization activities for GEN-009 and other product candidates, if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution, and manufacturing capabilities; and
|
•
|
revenue received from commercial sales of our product candidates.
|
•
|
The COVID-19 pandemic has materially affected our ability to conduct research, principally to explore InhibigenTM biology and ways to further strengthen ATLAS and other program opportunities.
|
•
|
The health and wellbeing of our employees and suppliers is at risk- if a critical threshold of our personnel, or the personnel of our suppliers, were to be diagnosed with COVID-19, placed in quarantine due to potential exposure to COVID-19, or need to care for family members diagnosed with COVID-19, it may result in significant manufacturing and business disruption.
|
•
|
Our clinical sites may no longer be able to continue with the GEN-009 clinical trial or limit patient enrollment which could have a material impact on our milestones and timelines. Further, clinical sites may not be engaging in new clinical programs which could have a material impact on our GEN-011 program.
|
•
|
We have asked most employees who are not directly involved in our GEN-009 and GEN-011 clinical programs to work from home, which could impact our ability to effectively plan, execute, communicate and maintain our corporate culture. The increase in working remotely could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations.
|
•
|
Stay at home orders have significantly limited the ability of individuals from traveling outside the home which may limit our ability to hire new employees or backfill terminated employees.
|
•
|
Equity and debt markets have experienced significant volatility since the spread of COVID-19 into the United States. Should significant volatility continue or they experience declines due to the economic impact of COVID-19, we may not be able to raise capital at a reasonable valuation or at all.
|
Exhibit
Number
|
|
Exhibit
|
10.1*
|
|
|
|
|
|
10.2*
|
|
|
|
|
|
10.3*†
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1
|
|
|
|
|
|
32.2
|
|
|
|
|
|
101
|
|
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019, (ii) Condensed Consolidated Statements of Operations and Comprehensive Income for the three months ended March 31, 2020 and 2019, (iii) Condensed Consolidated Statements of Stockholders' Equity (Deficit) for the three months ended March 31, 2020 and 2019, (iv) Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2020 and 2019 and (v) Notes to Unaudited Condensed Consolidated Financial Statements
|
|
Genocea Biosciences, Inc.
|
|
|
|
|
Date: April 30, 2020
|
By:
|
/s/ WILLIAM D. CLARK
|
|
|
William D. Clark
|
|
|
President and Chief Executive Officer and Director
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: April 30, 2020
|
By:
|
/s/ DIANTHA DUVALL
|
|
|
Diantha Duvall
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
Name:
|
[___________]
|
Number of Restricted Stock Units subject to Award:
|
[___________]
|
Date of Grant:
|
[___________]
|
(a)
|
“Beneficiary” means, in the event of the Grantee’s death, the beneficiary named in the written designation (in a form acceptable to the Administrator) most recently filed with the Administrator by the Grantee prior to the Grantee’s death and not subsequently revoked, or, if there is no such designated beneficiary, the executor or administrator of the Grantee’s estate. An effective beneficiary designation will be treated as having been revoked only upon receipt by the Administrator, prior to the Grantee’s death, of an instrument of revocation in form acceptable to the Administrator.
|
(a)
|
Vesting. Unless earlier terminated, forfeited, relinquished or expired, one-fourth (1/4) of the Restricted Stock Units will vest on each of the first four (4) anniversaries of the Date of Grant, with the number of Restricted Stock Units that vested on any such date being rounded down to the nearest whole Restricted Stock Unit and the Award becoming vested as to one hundred percent (100%) of the Restricted Stock
|
(b)
|
Forfeiture. Automatically and immediately upon the cessation of the Grantee’s Employment (i) the unvested portion of the Award will terminate and be forfeited for no consideration, and (ii) the vested portion of the Award, if any, will terminate and be forfeited for no consideration if the Grantee’s Employment is terminated in connection with an act or failure to act constituting Cause (as the Administrator, in its sole discretion, may determine), or such termination of Employment occurs in circumstances that in the determination of the Administrator would have entitled the Company and its subsidiaries to terminate the Grantee’s Employment for Cause.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Genocea Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark
|
|
President and Chief Executive Officer and Director
|
|
(Principal Executive Officer)
|
Date: April 30, 2020
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Genocea Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ DIANTHA DUVALL
|
|
Diantha Duvall
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
Date: April 30, 2020
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark
|
|
President and Chief Executive Officer and Director
|
|
(Principal Executive Officer)
|
Date: April 30, 2020
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ DIANTHA DUVALL
|
|
Diantha Duvall
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
|
|
Date: April 30, 2020
|
|